International Journal of Gynecology and Obstetrics (2008) 103, 227–231
a v a i l a b l e a t w w w. s c i e n c e d i r e c t . c o m
w w w. e l s e v i e r. c o m / l o c a t e / i j g o
CLINICAL ARTICLE
A comparison of vaginal, laparoscopic-assisted vaginal, and minilaparotomy hysterectomies for enlarged myomatous uteri Francesco Sesti ⁎, Francesca Calonzi, Velia Ruggeri, Adalgisa Pietropolli, Emilio Piccione Section of Gynecology and Obstetrics, School of Medicine, Tor Vergata University Hospital, Rome, Italy
Received 4 June 2008; received in revised form 10 July 2008; accepted 10 July 2008
KEYWORDS Enlarged uterus; Uterine myomas; Laparoscopic-assisted vaginal hysterectomy; Minilaparotomy hysterectomy; Vaginal hysterectomy
Abstract Objective: To compare the operative data and early postoperative outcome of vaginal hysterectomy (VH), laparoscopic-assisted vaginal hysterectomy (LAVH), and minilaparotomy hysterectomy (MiniLPT). Methods: A total of 150 women who required hysterectomy for enlarged myomatous uteri were randomly allocated into 3 treatment groups: VH (n= 50), LAVH (n= 50), and MiniLPT (n= 50). The primary outcome was hospital discharge time. The secondary outcomes were operative time, blood loss, paralytic ileus, postoperative pain, and intraoperative and early postoperative complications. Results: Mean hospital discharge time was longest with MiniLPT, and shortest with VH (P b 0.01). VH was the fastest operating technique, was associated with less blood loss, and resulted in shortest duration of paralytic ileus (P b 0.01). No intraoperative complications occurred. Conclusion: VH should be the preferred surgical approach in patients with enlarged myomatous uteri. When VH is not feasible, LAVH should be considered an alternative to MiniLPT. Further controlled prospective studies are required to confirm these results. © 2008 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction Hysterectomy is a major gynecological operative procedure, often performed for symptomatic myomas. However, there is no universal agreement on the optimum method of hyster⁎ Corresponding author. Section of Gynecology and Obstetrics, Department of Surgery, School of Medicine, Tor Vergata University Hospital, Viale Oxford 81, 00133 Rome, Italy. Tel./fax: +39 06 2090 2921. E-mail address:
[email protected] (F. Sesti).
ectomy [1]. The route for hysterectomy is based on clinical and technical factors [2–4]. In the literature, randomized trials have compared the operative and early postoperative outcomes of the various methods of hysterectomy [5–7]. Vaginal hysterectomy (VH) offered significant benefits in terms of reduced hospital stay and improved patient recovery compared with abdominal hysterectomy (AH), even in patients with an enlarged uterus [8–10]. VH was associated with significantly shorter operating time and lower costs compared with laparoscopic hysterectomy, with no detectable difference in
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228 quality of life measures or complication rates [10,11]. Laparoscopic-assisted vaginal hysterectomy (LAVH) resulted in less postoperative pain and shorter hospital stay compared with AH, but longer operating time than VH and AH [5]. LAVH was also safely performed in patients with a large uterus, despite the increased operating time and blood loss [5]. More recently, minilaparotomy hysterectomy (MiniLPT) has been proposed as an alternative and less invasive surgical procedure compared with classic AH [12,13]; however, in comparison with LAVH, MiniLPT was associated with a longer operating time, more postoperative pain, and higher complication rates [14]. To our knowledge, MiniLPT has not been compared with VH. The aim of the present study was to undertake a randomized trial to compare the operative data and early postoperative outcomes of VH, LAVH, and MiniLPT in a series of patients with symptomatic myomas and enlarged uteri.
2. Materials and methods The trial was performed in the gynecology section of Tor Vergata University Hospital, Rome, Italy. Between May 2005 and September 2007, all women with symptomatic uterine myomas requiring
F. Sesti et al. hysterectomy were considered eligible for the study. Inclusion criteria were presence of symptomatic or rapidly growing myomas, age less than 55 years, and uterine size greater than or equal to 12 weeks of gestation. Exclusion criteria were nulliparous women, uterine size greater than or equal to 16 weeks of gestation, previous uterine surgery, and suspicion of malignant gynecological disease. The local Ethics Committee and Institutional Review Board approved the study. Of 189 women requiring hysterectomy, 178 fulfilled the inclusion criteria and were recruited to the trial; of these, 28 women declined to participate. Written informed consent was obtained from each patient before randomization. Enrolment was closed when 150 consecutive patients were included and 50 patients were allocated to each arm. Patients were randomized the day before surgery (Fig. 1). The randomization procedure was based on a computer-generated list using serially numbered, opaque, sealed envelopes. A physician blinded to the groups randomly assigned each patient to VH, LAVH, or MiniLPT. The sequence was concealed until the interventions were assigned. Those performing the surgical procedures did not know which patients had been included in the study. Those assessing the outcomes were blinded to the group assignment. All procedures
Figure 1 Participant flow through the study. Abbreviations: VH, vaginal hysterectomy; LAVH, laparoscopic-assisted vaginal hysterectomy; MiniLPT, minilaparotomy hysterectomy.
A comparison of VH, LAVH, and MiniLPT for enlarged myomatous uteri were performed by 2 equally skilled and experienced surgeons using identical techniques. A standard preoperative assessment was performed together with an abdominal and transvaginal ultrasound to estimate the size, number, and site of the myomas as well as uterine size. Intraoperative prophylactic antibiotic therapy using an ampicillin sodium/sulbactam sodium combination was administered to all patients. Gonadotropin-releasing hormone agonists were not administered. Postoperative pain was controlled with intravenous administration of ketorolac and tramadol. VH was carried out as described by Dargent [15]. If the uterine size did not allow easy exteriorization, bisecting, coring, morcellation, enucleation of myomas or combinations of these volume-reducing techniques were performed [8]. LAVH type ID (dissection up to but not including uterine arteries plus anterior structures, and posterior culdotomy) according to the AAGL Classification System for Laparoscopic Hysterectomy [16] was performed under laparoscopic guidance. Laparoscopy was performed with a 10-mm principal trocar, introduced through the umbilicus and 2 ancillary 5-mm trocars. MiniLPT was performed using a 4–7-cm suprapubic incision as previously described [17]. The subcutaneous fat and the abdominal fascia were transversely opened 2 cm above the skin incision. The abdominal muscle and the parietal peritoneum were longitudinally opened on the midline. The primary outcome was the difference in hospital discharge time (measured in hours) among the 3 procedures. This was chosen as the primary outcome because, in general, it is influenced by the main operative data. Before hospital discharge the patients had to tolerate a normal diet, be able to dress themselves, be fully mobile, without fever, and not require analgesics. The secondary outcomes were differences in the main operative data: operating time (calculated from skin or vaginal incision to closure); blood loss (estimated by calculating the blood volume of the suction machine during surgery excluding liquid utilized for intraperitoneal washing, and by weighing swabs); paralytic ileus time (calculated in hours from the end of the procedure to the ability to pass feces or gas); intraoperative complications; febrile morbidity (oral temperature of 38 °C on 2 occasions 6 hours apart excluding the first 24 hours following surgery); intensity of postoperative pain; and early postoperative complications (any unfavorable episodes occurring Table 1
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within 30 days after surgery requiring readmission, blood transfusion, or repeat surgery). Intraoperative complications were bowel, urinary or vascular damage. Postoperative pain was assessed at 24 hours using a visual analog scale (VAS) that consisted of a nongraduated 10-cm line ranging from 0 (no pain) to 100 (pain as bad as it could be). Women were subdivided in 5 VAS score categories: absence of pain (0); mild pain (1–25); moderate pain (26–50); severe pain (51–75); and very severe pain (76–100). A power calculation verified that greater than 36 patients in each group would be necessary to detect a difference of more than 24 hours in discharge time with an alpha error level of 5% and a beta error of 80%. Statistical analysis was performed using SPSS (SPSS, Chicago, IL, USA). Continuous outcome variables were analyzed using the t test. Discrete variables were analyzed with the v2 test or Fisher exact test. The 3 treatment groups were compared using a 1-way analysis of variance (ANOVA) followed by the Turkey test for posthoc comparison of the mean values. A general linear model (GLM) procedure was also used to investigate interactions between variables (regression analysis). P b 0.05 was considered statistically significant.
3. Results Age, body mass index (BMI, calculated as weight in kilograms divided by height in meters squared), parity, uterine weight, and symptoms were similar among the 3 groups (Table 1). The procedures were performed successfully in all patients. Mean operating time was significantly shorter with VH than with MiniLPTand LAVH (P b 0.01). In the comparison between MiniLPT and LAVH, there was no significant difference regarding mean operating time (P N 0.05). The blood loss, considered a dependent variable in the GLM analysis, significantly influenced operating time (P= 0.01), and this effect was particularly strong for LAVH (P b 0.01). In contrast, uterine weight, also considered a dependent variable in the GLM analysis, did not have any effect on operating time (P= 0.40). Intraoperative blood loss was lower with VH than with MiniLPT and LAVH. No intraoperative complications occurred. With regard to early postoperative complications, 3 cases of bleeding were observed: 1 patient
Patient characteristics, operative data, and early postoperative outcomes a MiniLPT (n = 50)
Patient characteristics Age, y BMI Parity Uterine weight, g Operative data Operating time, min Blood loss, mL Conversion to laparotomy Intraoperative complications Early postoperative outcomes Paralytic ileus time, h Hospital discharge time, h Postoperative complications
47.7 ± 0.6 25 ± 0.7 2.2 ± 0.1 369 ± 25 133 ± 7 474.8 ± 43 0 (0) 0 (0) 32 ± 1.6 95 ± 6.5 1 (0.5)
VH (n = 50)
LAVH (n = 50)
P value
47.8 ± 0.5 26.4 ± 0.6 2.0 ± 0.2 330 ± 19
49 ± 0.7 24.8 ± 0.6 2.1 ± 0.2 345 ± 21
0.42 0.63 0.70 0.53
70 ± 3 181.0 ± 48 0 (0) 0 (0) 18 ± 2 46 ± 2.8 0 (0)
125 ± 6 351.6 ± 55 0 (0) 0 (0) 28 ± 3 70 ± 3.9 2 (1)
b 0.01 b 0.01 NS NS b 0.01 b 0.01 0.36
Abbreviations: MiniLPT, minilaparotomy hysterectomy; VH, vaginal hysterectomy; LAVH, laparoscopic-assisted vaginal hysterectomy; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); NS, not significant. a Values are given as mean ± SD or number (percentage).
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Figure 2 Postoperative pain intensity assessed at 24 hours using a visual analog scale.
who underwent MiniLPT required surgical removal of a hematoma, and 2 patients in the LAVH group required blood transfusion. No conversion to standard laparotomy was necessary in either group. The mean hospital discharge time was longer with MiniLPT than with VH and LAVH (P b 0.01) (Table 1). Both operating time and blood loss had an effect on discharge time, considered a dependent variable in GLM analysis (P b 0.05). The mean paralytic ileus time was significantly shorter after VH than LAVH and MiniLPT. In the comparison between MiniLPT and LAVH, the former showed a significantly longer paralytic ileus time. Operating time had an influence on paralytic ileus time (P b 0.01). Fig. 2 shows the differences among the 3 groups regarding postoperative abdominal pain intensity at 24 hours. Fifty percent of women reported absence of pain after VH, 30% after MiniLPT, and 15% after LAVH. Women who underwent MiniLPT and LAVH had postoperative pain more frequently compared with the VH group (P b 0.01). Postoperative fever was observed in only 3 women, 2 after MiniLPT and 1 after LAVH.
4. Discussion The aim of the present study was to compare the operative data and early postoperative outcomes of VH, LAVH, and MiniLPT in a series of patients with symptomatic myomas and enlarged uteri who had been randomly assigned to each surgical technique. To eliminate bias in our study, we adopted strict criteria for patient selection. Nulliparity and previous uterine surgery can be considered relative, and not absolute, contraindications for vaginal hysterectomy. However, we preferred to exclude nulliparous women and patients with previous uterine surgeries (such as cesarean delivery), both reported to hinder vaginal surgery [8], to ensure homogeneity of the 3 groups of women following randomization. Moreover, to make certain that uterine weight was comparable in the 3 groups, we included women with uterine sizes equivalent to between 12 and 16 weeks of gestation. Considering the importance of an individual surgeon's experience in laparoscopic and vaginal surgery, all procedures were performed by 2 equally skilled and experienced surgeons using identical laparoscopic, vaginal, and laparotomic techniques.
F. Sesti et al. In the LAVH group, the level of laparoscopic assistance was decided a priori and limited to type ID to evaluate the accessibility and mobility of the uterus; to exclude the presence of problems such as adhesions; to secure the round ligaments and ovarian or infundibulopelvic ligaments; and to dissect the structures located anterior and posterior to uterus. In the MiniLPT group, a 4–7-cm suprapubic incision was performed in relation to the diameter and position of the myomas. A wide variation in what clinicians call ‘‘minilaparotomy’’ makes a definition impossible and potentially misleading. Pelosi et al. [18] consider a laparotomy to be a minilaparotomy when the incision is 2.5–5 cm, Glasser et al. [19] define it when the incision is 3–6 cm, and others define it using an incision length of up to 10 cm [12,13]. Clearly, a standard universally accepted definition of ‘‘minilaparotomy’’ would be useful to assist in comparison of the results of the different studies. Johnson et al. [3] reported that LAVH and AH require longer operating times than VH, and this has been observed by others [5,7,20,21]. The mean operating time was significantly shorter with VH in the present study (P b 0.01). We suspect that the setup for LAVH may cause a longer operative time than VH. In our study, the operating time was strongly influenced by the intraoperative blood loss, particularly for the LAVH group. Although other studies have reported conflicting results [7,21], in our study the LAVH group showed greater blood loss compared with VH (P b 0.01). Because uterine weight and the other surgical factors were homogeneous in the 3 groups, and uterine weight did not have an effect on operating time (P= 0.40) nor on the blood loss (P N 0.05), it is difficult to explain this finding. It is not clear whether the laparoscopic or transvaginal route is better for the division of the uterine vessels. Kohler et al. [22] observed less bleeding during the vaginal step when the uterine vessels were transected laparoscopically. On the other hand, the transvaginal approach may be associated with retrograde bleeding, especially when uterine morcellation is necessary, as found by Unger et al. [23]. The approach taken for the uterine vessels, either vaginal or laparoscopic, could explain the difference in blood loss seen in the various studies. To clarify this issue it would be interesting to compare the blood loss associated with LAVH type I (not involving laparoscopic occlusion and division of the uterine arteries) and type II (involving laparoscopic occlusion and division of the uterine arteries) [16]. In the present study the MiniLPT group had greater blood loss compared with VH and LAVH (P b 0.01), which is in agreement with the comparative data for AH, VH, and LAVH [5,8,24], but not with the single comparative trial for LAVH and MiniLPT by Muzii et al. [14]. With regard to early postoperative outcome, the VH group had a significantly shorter mean paralytic ileus time compared with the other groups (Pb 0.01). Because MiniLPT requires a greater extent of peritoneal opening and more visceral handling, whereas these are analogous in VH and LAVH, this finding could be explained by the shorter operating time of VH. In fact, operating time had an influence on paralytic ileus time, which was considered a dependent variable in GLM analysis (Pb 0.01). Mean hospital discharge time was significantly shorter with VH than with MiniLPT and LAVH (P b 0.01). Blood loss had an influence on the discharge time, which was considered a dependent variable in GLM analysis (P b 0.05). In the literature, data on hospital discharge time after the 3 methods of hysterectomy are at odds. Garry et al. [20] found a longer discharge time with LAVH, while other studies have shown comparable
A comparison of VH, LAVH, and MiniLPT for enlarged myomatous uteri discharge times among the 3 methods [1,3,7,21]. The different discharge criteria applied could justify these differences. The present study adopted rigid criteria and the patients returned home only when they were tolerant of a normal diet, fully mobile, without fever, and did not require analgesics. Finally, women who underwent MiniLPTand LAVH complained of pain more frequently than women in the VH group (Pb 0.01). No significant difference was found among the 3 groups regarding the occurrence of early postoperative complications. The most recent literature on hysterectomy for enlarged myomatous uteri shows that the vaginal approach is employed more frequently for small or medium-sized uteri. With LAVH, abdominal–pelvic exploration and the ability to perform oophorectomy safely represent the main advantages compared with VH. The specific indications for each of the hysterectomy techniques remain uncertain. However, the purpose of LAVH is not to replace VH, but rather to increase the abilities of the gynecological surgeon to perform minimally invasive surgery for extended indications, and avoiding the need for an abdominal hysterectomy in the presence of adnexal tumors, tubo-ovarian adhesions, endometriosis, or previous pelvic surgery. Currently, the choice of surgical approach appears to depend more on the skill and experience of the surgeon than on the medical conditions. Although the selected surgical technique is fundamentally based on the surgeons' experience, women must be informed of the various surgical alternatives, and on their respective risks and benefits. In conclusion, VH proved to be valuable even for large uteri. It was the fastest operating technique, and it was associated with less blood loss compared with LAVH and MiniLPT. MiniLPT required a longer hospital stay, resulted in greater intraoperative blood loss, and had a longer operating time compared with VH and LAVH. VH should be the preferred surgical approach in women with an enlarged myomatous uterus. When VH is not feasible, LAVH should be considered as an alternative to MiniLPT. However, further controlled prospective studies are required to confirm our results to identify the best approach for hysterectomy in women with enlarged myomatous uteri.
Acknowledgements The study was funded by the Italian Ministry of Education.
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